Background
In 14 years to 2014, the Food and Drug Administration (FDA) approved 88 new anticancer therapies, of these 38 (43%) were oral anticancer therapies (OACT).
Complex regulatory and reimbursement processes are common prior to Pharmaceutical Benefits Scheme (PBS) access; the average time between Therapeutic Goods Administration (TGA) submission and PBS listing is currently 14 months. A 2012 review found up to 42.2% of anticancer treatments approved for use in Australia were off-label and/or unfunded by the PBS.
Many newer OACT not licensed in Australia are accessible via compassionate access programs (CAPs). Information on these therapies can be difficult to obtain and often result in increased waiting times for patients. Non-standardised sources of information can lead to inconsistencies in practice and errors in dosing, monitoring and labelling. To our knowledge, there is currently no single resource for OACT that summarises information required at the point of dispensing and counselling.
Aim
To develop a point-of-care quick reference manual to standardise the dispensing and clinical checking process for OACT.
Methods
A working group was convened to develop and implement a manual containing an overview of important information relating to OACT. 57 medications (including 19 CAPs) were included and data was obtained from reputable references including drug company provided sources. Information for each medication including indications, interactions, side effects, counselling points, monitoring parameters and dosing instructions was collated into a table.
Discussion
OACT have complex dosing instructions which may be difficult for patients to interpret. Many are susceptible to interactions, and have complex pharmacokinetic and pharmacodynamics profiles prompting consideration for dose adjustments. The inclusion of monitoring parameters and pharmacokinetic data has allowed pharmacists to easily identify drug interactions, abnormal laboratory results and dosing/scheduling problems.
Conclusion
The implementation of an OACT reference manual has standardised pharmacy processes resulting in consistency and improved patient outcomes.